背景:尽管有成千上万的心理健康应用程序,2个应用程序,顶部空间和平静,占据了市场的很大一部分。这两个正念和冥想应用程序已经达到了数千万的活跃用户。引导消费者,临床医生,和研究人员,我们对顶空和镇静的随机对照试验(RCTs)进行了系统评价.
目的:我们的研究旨在评估干预效果,偏见的风险,以及“顶空与平静”证据基础中的利益冲突(COIs),我们搜索时最受欢迎的两个心理健康应用程序。
方法:为了确定研究,我们搜索了学术数据库(谷歌学者,MEDLINE,和PsycINFO)以及2021年5月的HeadspaceandCalm网站,通过原始数据收集进行HeadspaceandCalm测试功效的RCT,在同行评审期刊上以英文发表。对于每一项研究,我们编码了(1)研究特征(例如,参与者,样本量,和结果衡量标准),(2)干预特征(例如,免费与付费版本的应用程序和预期的应用程序使用频率),(3)所有研究结果,(4)偏差变量的Cochrane风险,和(5)COI变量(例如,是否存在预注册以及是否存在涉及公司的COI声明)。
结果:我们确定了14个顶空RCT和1个CalmRCT。总的来说,93%(13/14)的顶部空间RCTs和100%(1/1)的CalmRCTs招募了来自非临床人群的参与者。通常测量正念的研究,幸福,压力,抑郁症状,和焦虑症状。在75%的评估结果的研究中,顶空使用改善了抑郁症。正念的发现好坏参半,幸福,压力,和焦虑,但至少40%的研究显示这些结局均有所改善.研究通常不足以检测“小”或“中”效应大小。此外,50%(7/14)的顶部空间RCT和0%(0/1)的CalmRCT报告了涉及顶部空间或Calm(公司)的COI。最常见的COI是为参与者免费提供高级应用程序访问的应用程序公司,尤其是,14%(2/14)的顶部空间RCT报告顶部空间员工参与研究设计,执行,和数据分析。只有36%(5/14)的顶部空间随机对照试验被预先登记,并且Calm的1个RCT没有预先注册。
结论:顶空的实证研究似乎很有希望,而没有关于Calm的随机试验。这项研究的局限性包括由于缺乏研究Calm的RCT以及依赖作者报告来评估COIs而无法比较顶部空间和Calm。在确定心理健康应用程序是否具有高质量时,应确保识别高质量的应用程序并评估其有效性和调查人员的COIs。
BACKGROUND: Although there are thousands of mental health apps, 2 apps, Headspace and Calm, claim a large percentage of the marketplace. These two mindfulness and meditation apps have reached tens of millions of active users. To guide consumers, clinicians, and researchers, we performed a systematic
review of randomized controlled trials (RCTs) of Headspace and Calm.
OBJECTIVE: Our study aimed to evaluate intervention efficacy, risk of bias, and conflicts of interest (COIs) in the evidence base for Headspace and Calm, the two most popular mental health apps at the time of our search.
METHODS: To identify studies, we searched academic databases (Google Scholar, MEDLINE, and PsycINFO) and the websites of Headspace and Calm in May 2021 for RCTs of Headspace and Calm testing efficacy via original data collection, published in English in peer-reviewed journals. For each study, we coded (1) study characteristics (eg, participants, sample size, and outcome measures), (2) intervention characteristics (eg, free vs paid version of the app and intended frequency of app usage), (3) all study outcomes, (4) Cochrane risk of bias variables, and (5) COI variables (eg, presence or absence of a preregistration and the presence or absence of a COI statement involving the company).
RESULTS: We identified 14 RCTs of Headspace and 1 RCT of Calm. Overall, 93% (13/14) of RCTs of Headspace and 100% (1/1) of RCTs of Calm recruited participants from a nonclinical population. Studies commonly measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms. Headspace use improved depression in 75% of studies that evaluated it as an outcome. Findings were mixed for mindfulness, well-being, stress, and anxiety, but at least 40% of studies showed improvement for each of these outcomes. Studies were generally underpowered to detect \"small\" or \"medium\" effect sizes. Furthermore, 50% (7/14) of RCTs of Headspace and 0% (0/1) of RCTs of Calm reported a COI that involved Headspace or Calm (the companies). The most common COI was the app company providing premium app access for free for participants, and notably, 14% (2/14) of RCTs of Headspace reported Headspace employee involvement in study design, execution, and data analysis. Only 36% (5/14) of RCTs of Headspace were preregistered, and the 1 RCT of Calm was not preregistered.
CONCLUSIONS: The empirical research on Headspace appears promising, whereas there is an absence of randomized trials on Calm. Limitations of this study include an inability to compare Headspace and Calm owing to the dearth of RCTs studying Calm and the reliance on author reports to evaluate COIs. When determining whether or not mental health apps are of high quality, identification of high-quality apps and evaluation of their effectiveness and investigators\' COIs should be ensured.